Treatment of skin and soft tissue cancers using alpha radiation emitters
A Safety and Effectiveness Study of Intratumoral Diffusing Alpha Radiation Emitters for the Treatment of Malignant Cutaneous, Mucosal or Superficial Soft Tissue Neoplasia
This study is testing a new treatment that uses tiny radioactive seeds placed directly into skin and soft tissue cancers to see if it can shrink tumors while keeping healthy tissue safe.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Alpha Tau Medical LTD. Industry-sponsored |
| Drugs / interventions | radiation |
| Locations | 1 site (Haifa) |
| Trial ID | NCT03889899 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the safety and efficacy of a novel treatment method using diffusing alpha radiation emitters (DaRT) for patients with superficial cutaneous, mucosal, or soft tissue neoplasms. The approach involves inserting radioactive seeds directly into the tumor, allowing for localized radiation therapy that aims to reduce tumor size while minimizing exposure to surrounding healthy tissue. The study will assess tumor reduction 70 days post-treatment and monitor adverse events to ensure patient safety.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 with confirmed malignant skin or soft tissue tumors measuring 7 cm or less.
Not a fit: Patients with keratoacanthoma tumors or significant comorbidities that may interfere with the study's endpoints are unlikely to benefit.
Why it matters
Potential benefit: If successful, this treatment could provide a more effective and targeted option for patients with superficial cancers, potentially leading to better outcomes and fewer side effects.
How similar studies have performed: While the use of alpha radiation in cancer treatment is a novel approach, similar localized radiation therapies have shown promise in other studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Subjects with histopathological confirmation of primary or secondary malignant cutaneous neoplastic lesions, or oral cavity mucosal tumors, or superficial soft tissue sarcoma. * Subjects with a tumor size ≤ 7 centimeters in the longest diameter. * Measurable disease according to RECIST v1.1. * Subjects over 18 years old. * Subjects' ECOG Performance Status Scale is \< 2. * Subjects' life expectancy is more than 6 months. * Platelet count ≥100,000/mm3. * International normalized ratio of prothrombin time ≤1.8. * Creatinine ≤1.9 mg/dL. * Women of childbearing potential (WOCBP) will have evidence of negative pregnancy test. * Subjects are willing to sign an informed consent form. Exclusion Criteria: * Subject has a tumor of Keratoacanthoma histology. * Patients with significant comorbidities that the treating physician deems may conflict with the endpoints of the study (e.g., poorly controlled autoimmune diseases, vasculitis, etc.) * Patients undergoing systemic immunosuppressive therapy excepting intermittent, brief use of systemic corticosteroids * Volunteers participating in another interventional study in the past 30 days which might conflict with the endpoints of this study or the evaluation of response or toxicity of DaRT. * High probability of protocol non-compliance (in opinion of investigator). * Subjects not willing to sign an informed consent. * Women who are pregnant or breastfeeding.
Where this trial is running
Haifa
- RAMBAM Health Care Campus — Haifa, Israel (Recruiting)
Study contacts
- Principal investigator: Tomer Charas, MD — Radiotherapy unit at Rambam Health Care Campus, Israel
- Study coordinator: Liron Dimnik
- Email: LironD@alphatau.com
- Phone: +972-2-373-7000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.